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Parasite Suspensions
EUDAMEDFDA UDIClass B (EU MDR)
Ref [FP12] Parasite Suspensions Endolimax nanaModel FP12
Identity
- Trade Name
- Parasite Suspensions FDA UDI
- Generic Name
- Multiple faecal parasite antigen IVD, control FDA UDI
- Device Name
- Parasite Suspensions EUDAMEDParasite Suspensions Endolimax nana FDA UDI
- Model / Reference
- FP12 EUDAMEDFDA UDI[FP12] Parasite Suspensions Endolimax nana EUDAMED
- Description
- Parasite Suspensions Endolimax nana FDA UDI
Identifiers
- Catalog Number
- FP12 FDA UDI
- Primary DI / UDI-DI
- 10845357035537 EUDAMEDFDA UDI
- Basic UDI-DI
- 08453570FP12J9 EUDAMED
- FDA Product Code
- LIB FDA UDI
- EMDN Code
- W01040699 CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER EUDAMED
- GMDN Term
- Multiple faecal parasite antigen IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2660 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Parasite Suspensions by Microbiologics, Inc. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 08453570FP12J9 | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Microbiologics, INC.
- EUDAMED SRN
- US-MF-000000466
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED 82fea053-fc99-4d75-929a-3f1b1c2d21b5 61 fields · synced Jun 18, 2026
- FDA UDI c28033fd-d579-4351-8c79-520cfce7eaf4 36 fields · synced May 29, 2026